Aprea Therapeutics has dosed a subject with human papillomavirus (HPV)-positive head and neck squamous cell carcinoma (HNSCC) in Cohort 5 of the Phase I ACESOT-1051 trial evaluating APR-1051.
In this cohort, 70mg of the therapy one-time-a-day is given.
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The trial, which is assessing monotherapy APR-1051 in individuals with advanced solid tumours, has enrolled the latest subject at MD Anderson Cancer Center, US.
This centre is the lead site, and the trial will be conducted at three to ten sites in the country.
A material transfer agreement (MTA) between the company and MD Anderson supports preclinical research into the therapy’s potential for treating both HPV+ and HPV—HNSCC expressing replication stress genomic markers.
The trial is structured to evaluate the pharmacokinetics, safety, preliminary efficacy, and pharmacodynamics of the therapy in advanced solid tumours harbouring cancer-associated gene alterations.
Oral administration of the therapy occurs one time a day in 28-day cycles, with Part 1 focusing on dose escalation, anticipating up to 39 subject enrolments.
The Bayesian Optimal Interval (BOIN) design is employed for dose levels of 50mg and above, following accelerated titration for the initial doses of 10mg, 20mg, and 30mg.
Part 2 will focus on dose optimisation and determine the recommended Phase II dose (RP2D).
The trial’s primary objectives are to measure RP2D, dose-limiting toxicities (DLTs), maximum tolerated dose or maximum administered dose (MTD/MAD), and safety.
Secondary objectives involve assessing pharmacokinetics and preliminary efficacy, while pharmacodynamics is an exploratory objective.
Aprea noted that the trial’s open-label data is anticipated in the latter half of this year.
Aprea Therapeutics WEE1 Clinical Development lead and senior medical advisor Philippe Pultar said: “We are pleased with the progress of the trial and encouraged by the safety profile of APR-1051 to date.
“We look forward to continuing the study as we work toward identifying the optimal dose for future studies.”
In January 2023, the company dosed the first subject in a Phase I/IIa study of ATRN-119.
